Sunesis Pharmaceuticals Announces Presentation of Preliminary Data from Phase 1b/2 Trial of Vecabrutinib in Patients with CLL...
December 02 2018 - 12:00PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
presentation of results from the Company’s Phase 1b/2 clinical
trial of its non-covalent BTK inhibitor vecabrutinib in adults with
relapsed/refractory chronic lymphocytic leukemia (CLL) and other
B-cell malignancies. The results will be presented today, December
2, from 6:00-8:00 p.m. PT in a poster session titled “CLL: Therapy,
excluding Transplantation: Poster II” at the 60th American Society
of Hematology (ASH) Annual Meeting in San Diego, California. The
poster, titled “Preliminary Safety, Pharmacokinetic, and
Pharmacodynamic Results from a Phase 1b/2 Dose-Escalation and
Cohort-Expansion Study of the Noncovalent, Reversible Bruton’s
Tyrosine Kinase Inhibitor, Vecabrutinib, in B-Lymphoid Malignancy
Patients with Prior BTKi Therapy,” Abstract No. 3141, is available
at www.sunesis.com.
“To date, vecabrutinib has demonstrated both an
encouraging safety profile and evidence of pharmacodynamic activity
in CLL and other B cell cancer patients both with and without the
BTK C481 mutation,” said Dayton Misfeldt, Sunesis interim Chief
Executive Officer. “We believe vecabrutinib has significant
potential to be an important new treatment for ibrutinib-resistant
B-cell malignancy patients, and its additional activity as an ITK
inhibitor suggests further directions for clinical investigation.
We look forward to continuing the dose escalation, as we believe
that the target dose level is likely to be between 100 mg and 300
mg BID. We are excited to be working with such thoughtful and
diligent investigators at eight premier sites across the U.S., and
we thank our investigators for their continued support.”
Data reported today were available from 11 of 13
treated patients. These included 7 with relapsed/refractory CLL,
two with mantle cell lymphoma (MCL), and two with Waldenstrom
macroglobulinemia (WM). Patients had received an average of 5 lines
of prior therapy, and all had progressed on prior covalent BTK
inhibitor treatment. Four of the 7 CLL patients had BTK C481
mutations. Currently, 4 patients are on study: one in Cycle 2, one
in Cycle 3, and two new subjects who are in Cycle 1 and are
anticipated to complete the 50 mg cohort.
The poster builds vecabrutinib’s profile in
three key areas:
- Safety: data on treatment-emergent adverse
events (TEAEs) were available for 10 patients. The most common
TEAEs of any grade were anemia (70%) and neutropenia and night
sweats (50% each). Grade 3 drug-related AEs were anemia,
neutropenia, leukocytosis, and ALT increase (10% each). In the
second cohort, one patient experienced a dose-limiting toxicity of
an inadequate number of Cycle 1 doses administered due to a
drug-related grade 3 ALT elevation, resulting in expansion of the
cohort to 6 patients.
- Pharmacokinetics: the pharmacokinetic profile
of the 50mg dose is approximately dose proportional to the 25 mg
dose. The next dose levels are expected to produce plasma
concentrations associated with consistently high inhibition of
BTK.
- Pharmacodynamics: vecabrutinib inhibition of
BTK phosphorylation was rapid and sustained in the 5 patients who
had adequate baseline signal for analysis. Decreases in serum
concentrations of key cytokines associated with B-cell
malignancies, CCL2, CCL3, and CCL4, were also observed in 7
patients, consistent with inhibition of BTK signaling.
Webcast Information
The data will be further discussed as part of an
analyst and investor event being held in San Diego today, December
2, at 8:00 p.m. PT, with the slide webcast commencing at 8:30 p.m.
PT. The event is intended for institutional investors and sell-side
analysts only. Please contact maeve@argotpartners.com for more
information. The live webcast of the event, with slides, will be
available to all on the Investors section of the Sunesis website at
www.sunesis.com and will be archived for 90 days.
About Vecabrutinib
Vecabrutinib (SNS-062) is a selective, oral,
reversible, non-covalent inhibitor of Bruton's tyrosine
kinase (BTK). BTK is a validated target for the treatment of
B-cell malignancies driven by B-cell receptor signaling.
Vecabrutinib retains its activity in the presence of a BTK C481S
mutation, the most common mutation seen in ibrutinib-resistant CLL
patients. In preclinical studies, vecabrutinib demonstrated potent
activity in both wild-type and C481S-mutant BTK. Vecabrutinib has
also been shown to inhibit a select number of other kinases
including IL2-inducible T-cell kinase (ITK), which may improve T
cell function. In a Phase 1a randomized, double-blind,
placebo-controlled single ascending dose study in healthy
volunteers, vecabrutinib demonstrated improved pharmacokinetics
over ibrutinib, and sustained inhibition of BTK. Vecabrutinib is
now being investigated in a Phase 1b/2 study in patients with
relapsed CLL and other B-cell malignancies.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company
developing new therapeutics for the treatment of hematologic and
solid cancers. Sunesis has built an experienced drug development
organization committed to improving the lives of people with
cancer. The Company is focused on advancing its novel kinase
inhibitor pipeline, with an emphasis on its oral non-covalent BTK
inhibitor vecabrutinib. Vecabrutinib is currently being evaluated
in a Phase 1b/2 study in adults with chronic lymphocytic leukemia
and other B-cell malignancies that have progressed after prior
therapies. The Company’s proprietary PDK1 inhibitor SNS-510 is in
preclinical development. PDK1 is a master kinase that activates
other kinases important to cell growth and survival including
members of the AKT, PKC, RSK, and SGK families. Sunesis plans to
submit an IND for SNS-510 in 2019. Sunesis is exploring strategic
alternatives for vosaroxin, a late-stage investigational product
for relapsed or refractory AML. Sunesis also has an interest in the
pan-RAF inhibitor TAK-580 which is licensed to Takeda. TAK-580 is
in a clinical trial for pediatric low-grade glioma.
For additional information on Sunesis, please
visit www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis
Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to the continued
development of vecabrutinib (SNS-062), including the timing and
preliminary results of Phase 1b/2 trial of vecabrutinib and the
therapeutic potential of vecabrutinib, further development and
potential of its kinase inhibitor pipeline, and planned development
of SNS-510 and TAK-580. Words such as “believe,” “expect,”
“future,” “look forward,” “potential,” “will,” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Sunesis' current
expectations. Forward-looking statements involve risks and
uncertainties. Sunesis' actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risk related
to the timing or conduct of Sunesis' clinical trials, including the
vecabrutinib Phase 1b/2 trial, the risk that Sunesis' clinical or
preclinical studies for vecabrutinib, SNS-510 or other product
candidate may not demonstrate safety or efficacy or lead to
regulatory approval, the risk that data to date and trends may not
be predictive of future data or results, risks related to the
timing or conduct of Sunesis' clinical trials, that Sunesis'
development activities for vecabrutinib or SNS-510 could be
otherwise halted or significantly delayed for various reasons, that
Sunesis may not be able to receive regulatory approval of
vecabrutinib, or SNS-510 in the U.S. or Europe, and risks related
to Sunesis' ability to raise the capital that it believes to be
accessible and is required to fully finance the development and
commercialization of vecabrutinib, SNS-510 and other product
candidates. These and other risk factors are discussed under "Risk
Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q
for the quarter ended September 30, 2018 and Sunesis' other filings
with the Securities and Exchange Commission. Sunesis
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein reflect any change in Sunesis' expectations with
regard thereto or any change in events, conditions or circumstances
on which any such statements are based.
Investor and Media
Inquiries:Maeve ConneightonArgot Partners212-600-1902 |
Willie
QuinnSunesis Pharmaceuticals Inc.650-266-3716 |
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